Spontaneous rupture of flexor tendons. Spontaneous rupture of flexor tendons
Conditions
Interventions
Intervention 1: Control group: The control group will receive nothing other that routine surgery process. Intervention 2: Intervention group: Amniotic membrane allograft group. In this group after the
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
19 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1- Male or female aged 19 to 60 years presenting to the surgery department with a zone 1 or 2 flexor tendon injury requiring surgical repair. 2- Provide written documentation of informed consent to participate in the study. 3- Subjects in the acute phase of the injury (diagnosed within 4 days after the injury). 4- Tendinous injuries on a single hand. 5- Total transection of the flexor tendon.
Exclusion criteria
Exclusion criteria: 1- Subjects suffering from osteoarthritis or rheumatic arthropathy. 2- Participants with Previous flexor tendon injuries in Zone 1-2 for the fingers. 3- Female patients that are pregnant or breastfeeding. 4- Subjects taking anti-coagulant or NSAIDs. 5- Severe crush, Degloving injuries, segmental tendon loss, or Soft-tissue loss preventing proper tissue suture. 6- Subjects with auto-immune diseases, type I-II Diabetes, sepsis, or gross wound contamination. 7- Drug abuse. 8- Fracture of the injured finger, or associated nerve injuries preventing rehabilitation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adhesion band formation post flexor tendon surgery. Timepoint: 1, 2, 4, 8 weeks, and 3 and 6 months. Method of measurement: Nair Scoring system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Active Motion (TAM) assessment of injured fingers post-surgery. Timepoint: 1, 2, 4, 8 weeks, and 3 and 6 months. Method of measurement: Total Active Motion (TAM) outcome measure.;Measuring the chronic pain of fingers post-operation. Timepoint: 1, 2, 4, 8 weeks, and 3 and 6 month. Method of measurement: By using Visual Analogue Scale (VAS).;Hand grip strength. Timepoint: 1, 2, 4, 8 weeks, and 3 and 6 month. Method of measurement: Jamar dynamometer.;Post-operative infection. Timepoint: 1, 2, 4, 8 weeks, and 3 and 6 month. Method of measurement: Observational analysis of injured tendon.;Frequency of rupture of the repaired tendon (Tear recurrence). Timepoint: 1, 2, 4, 8 weeks, and 3 and 6 month. Method of measurement: Observational analysis of injured tendon. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Mahdi Hassanian Mehr
Mashhad University of Medical Sciences
Outcome results
None listed